Key Responsibilities:
1) Functional & People Leadership
- Lead, manage, and develop all Manufacturing Engineers (molding, assembly, box build, sustaining, and lifecycle support).
- Own workforce planning, recruitment, onboarding, performance evaluation, coaching, succession planning, and competency development.
- Establish a clear team structure, role ownership, and escalation pathways to ensure effective support to production.
2) Engineering Governance & Systems
- Define, implement, and continuously improve Manufacturing Engineering systems, including:
- Engineering Change Control (ECN) governance, review, approval, and implementation discipline
- Standardized problem-solving methodology (8D/DMAIC) and corrective action effectiveness controls
- Process documentation standards and templates (process flow, WI, PFMEA, control plans and associated records)
- Establish Protocols for validation of machine and equipment as required for IQ, OQ, PQ, repeat and refurbish tooling
- Ensure robust document control, traceability, and revision management aligned to internal procedures and applicable regulatory/customer requirements.
3) Production Support & Technical Escalation
- Provide leadership oversight to troubleshoot production issues, line fallout, and field returns through structured root cause analysis and risk-based corrective actions.
- Drive reduction in defect rates, scrap, and rework through systematic containment, RCA, and prevention mechanisms.
- Ensure engineers maintain strong process control and discipline in daily production support.
- To determine tooling capacity to meet current and new demand and to access tooling condition for further action
4) Continuous Improvement & Performance Delivery
- Own and drive a site-wide continuous improvement roadmap to improve OEE (availability, performance, quality), yield, cycle time, and cost.
- Identify, prioritize, and execute improvement projects with measurable benefits; track realization and sustainment.
- Establish best practices and standardized methods/SOPs across lines and areas to ensure consistent output and quality.
5) ECN / Change Implementation Leadership
- Own end-to-end ECN management: evaluation, manufacturability assessment, risk/impact analysis, implementation planning, and post-change monitoring.
- Coordinate cross-functionally with Production, Quality, Supply Chain and Production Lifecycle Management (PLM) teams to ensure readiness (BOM/routing updates, training, inspection updates, material cut-in plan, validation needs).
- Monitor ECN outcomes to ensure production stability; trigger corrective actions if any negative trend is observed.
6) Customer & Stakeholder Management
- Act as the technical escalation owner for customer communications related to product changes, technical clarifications, improvement actions, and field feedback.
- Review customer change requests, assess risk and manufacturability, and drive internal actions to support product lifecycle improvements.
- Support customer audits, engineering reviews, and product discussions with accurate technical inputs, evidence-based updates, and disciplined follow-up actions.
7) Compliance, Audit Readiness & Reporting
- Ensure production records and engineering documentation are complete, accurate, and compliant with procedures (e.g., BOM, specifications, routing, revision control, validation records where applicable).
- Lead audit readiness for the engineering scope; ensure timely closure of audit findings with effective corrective actions.
- Review and approve monthly engineering performance reports; communicate trends, risks, and improvement plans to management.
8) Strategic Roadmap & Resource Management
- Propose and implement systems and initiatives that enhance manufacturing capability and production performance.
- Manage engineering budget for trials, tooling/fixtures, external services, and improvement projects; ensure ROI tracking where applicable.
- Partner with leadership to support capacity expansion, new process introduction, and technology upgrades (including automation readiness as relevant).
Requirements:
- Bachelor’s degree or above in Mechanical Engineering, Electrical Engineering, Mechatronics, Manufacturing Engineering, or related discipline.
- Preferred: electro-mechanical background and experience supporting equipment/process integration.
- At least 7 years of manufacturing engineering experience, including direct support of molding and/or assembly operations.
- Minimum 5 years of people leadership experience managing engineers or technical teams
- Proven experience in ECN/change control, customer-facing technical communication, and structured problem solving.
- Proven experience supporting manufacturing in a medical device environment with a working knowledge of ISO 13485 requirements
- Familiarity with medical electrical equipment safety requirements and manufacturing implications aligned to IEC 60601 (e.g., leakage current, dielectric strength/HiPot, protective earth continuity, labeling, configuration control).
Pay: RM10,000.00 - RM15,000.00 per month
Benefits:
- Health insurance
- Opportunities for promotion
- Parental leave
- Professional development
Work Location: In person